Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00184, 0001822565-2023-00185, and 0001822565-2023-00186.
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Event Description
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It was reported on a worn instrument return form that the instrument was missing bearings.There was no reported patient involvement.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual inspection of the returned item # 42527900502 lot # 62790817 found it to exhibit signs of repeated use and have one of components 42527991001 and 42527991002 disassembled / missing.The components were not returned.The device history record was reviewed and no discrepancies relevant to the reported event were found.This device is confirmed to have been a part of a previous investigation.Actions were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.These devices were subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that these devices were manufactured prior to this design change.The root cause is considered to be a previously addressed design issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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